Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation

Overview

Adenoid cystic tumors are rare tumors of the head and neck region. Despite their slow growth, re-irradiation is often necessary due to the high metastatic risk. Patients are usually irradiated with photons or, as here at the Heidelberg University Hospital, with a combination of carbon ions and photons. So far, there is no data from Europe available for the sole irradiation with carbon ions. The present ACCO (Adenoid Cystic Carcinoma and Carbon ion Only irradiation) study, a prospective, open-label, phase II, single-arm, investigator-initiated study, will therefore investigate the sole radiotherapy of carbon ions in this tumor entity. Irradiation is applied - significantly shorter than the combination therapy - in about 4 weeks (22 fractions); patients are followed up for further 5 years after the start of therapy. Carbon ions alone are expected to increase local tumor control rates from 60% to 70% after 5 years (primary objective criterion of this study). In order to reject the null hypothesis with a power of 80% and a significance level of 5%, 175 patients are included (including a drop-out rate of 15%). Secondary objective criteria are progression-free survival, overall survival, acute and late toxicity, and quality of life.

Interventions

• Radiation Carbon ion irradiation
  22 x 3 Gy(RBE) Carbon Ions
• Radiation Bimodal irradiation
  25 x 2 Gy photon IMRT + 8 x 3 Gy(RBE) Carbon ion boost

Primary outcome measures

• Freedom from loco-regional progression [Time frame: at 5 years]

Secondary outcome measures (4)

• Progression-free survival [Time frame: at 3 and 5 years]
• Overall survival [Time frame: at 3 and 5 years]
• Acute toxicities [Time frame: during and up to 6 weeks after radiotherapy]
• Late toxicities [Time frame: up to 5 years]

Eligibility criteria

Inclusion criteria

• Histologically confirmed adenoid cystic carcinoma in the head and neck area
• Indication for irradiation:
• non-operable or
• R1/R2 resected or
• perineural sheat invasion (Pn+) or
• pT3/pT4
• Informed consent
• KI > 60% or ECOG 0/1 (minimum: self-sufficiency, normal activity or work not possible)
• Age 18-80 years

Exclusion criteria

• rejection of the study by the patient
• Patient is not able to consent
• Stage IV (distant metastases), except lung metastases < 1cm
• lymph node involvement (clinical or pathological)
• Previous radiotherapy in the head and neck area
• Active medical implants for which there is no ion radiation authorization at the time of treatment (e.g., cardiac pacemaker, defibrillator, ...)
• Contraindication to MR imaging
• Simultaneous participation in another clinical study that could influence the outcome of this study or the other study
• Pregnancy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Germany · 1 center

• University of Heidelberg, Radiooncology, HIT — Heidelberg

Publications

• Lang K, Adeberg S, Harrabi S, Held T, Kieser M, Debus J, Herfarth K. Adenoid cystic Carcinoma and Carbon ion Only irradiation (ACCO): Study protocol for a prospective, open, randomized, two-armed, phase II study. BMC Cancer. 2021 Jul 15;21(1):812. doi: 10.1186/s12885-021-08473-5. PMID 34266402

Identifiers

NCT: NCT04214366 · ACCO

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗